FAQ

An investigator initiated research (abbreviated IIR) is a research effort where an investigator and/or sponsor is seeking support from Dompé US, Inc. ("Dompé") to conduct a clinical investigation.

An investigator is the individual who conducts the investigation (i.e. under whose immediate direction the investigational drug is administered or dispensed to a subject). An investigator of an IIR assumes the responsibilities of, and must comply with, FDA regulations applicable to both a sponsor and an investigator. These responsibilities include the submission and maintenance of an IND, regulatory responsibilities and manage the conduct of the study.

A sponsor takes responsibility for and initiates a clinical investigation. A sponsor can be an individual, a collaborative group of investigators, governmental agency, academic institution, pharmaceutical company, private organization, or other organization (e.g. patient advocacy organization).

Dompé may support an IIR with drug product and/or funding, and materials (including Dompé information, placebo, or other medicinal products necessary for the research).

Our current areas of interest are: Ophthalmology, Neurology (CNS), Otology, Diabetes, Oncology/Hematology, Respiratory, Pain, Metabolic, Immunology

• Clinical studies of Dompé Therapeutics marketed drugs for approved or investigational uses

• Clinical studies of Dompé Therapeutics investigational drug product (interventional, non-clinical, phase I to IV)

• Observational studies of real-world experience (retrospective, prospective, EHR, database or epidemiology, patient reported experience, HEOR) in areas of interest

• Non-clinical studies (animal or laboratory)

• Registries

• Literature Reviews or Meta-Analysis

• Possess the scientific, technical and operational capabilities to conduct the study, including adequately trained staff and statistical support

• Submit a well-designed protocol and budget. Please submit well defined study hypothesis, primary and secondary endpoints

• Develop and maintain the case report forms

• Initiate and monitor the study

• Comply with any and all pertinent laws, regulations, and guidelines (e.g. IND)

• Comply with any and all requirements of institution(s) with which they are associated or in which research will occur (e.g. IRB)

• Report safety data to regulatory authorities (FDA), the IRB and Dompé

• Provide periodic ongoing study updates to Dompé

• Submit a written report of the final study results to Dompé

• Submit abstract/publication to Dompé two weeks before submission to a journal or meeting

• If study results are published in a scientific journal, provide a copy of the manuscript to Dompé

• Provide approved support as outlined in the legal agreement in a timely manner

• Review the proposal and protocol for scientific integrity and study design to ensure patient well-being and provide a decision to the Investigator-initiator.

• An IIR concept proposal initially and finalized as a protocol

• Curriculum vitae of investigator or sub-investigators

• Everything begins with you registering in the Dompé IIR portal

• Once you have registered, you will then be able to submit concept proposals to Dompé

• Throughout this step and all phases of the process, the system will automatically notify you about various documentation requirements, such as your curriculum vitae, budget requests (if applicable), and milestone updates

• Once you have submitted a proposal, it will be reviewed by the Dompé IIR Committee. If there are any questions, you will receive notification from Dompé for clarification or additional information

• If the proposal is approved, you will then be invited to submit a detailed protocol and budget. Dompé medical personnel will review the protocol/budget in a similar fashion as the initial proposal review with a primary focus on the scientific integrity of the study design and overall patient well-being; the end result will be a similar set of decision outcomes as the initial proposal

• Once the protocol is approved, Dompé will then finalize contractual terms of the support being provided and expectations for you as the study sponsor

• After the contract is finalized and all supporting documentation has been obtained, you will then be ready to start the conduct of the study

• Throughout study conduct, Dompé will contact you for study progress reports and supporting documentation for any support payments, product shipment requests, etc.

• Once the study enrollment is complete, we will then move into closing out the study and enter the publications phase of the study (final deliverables from the study as defined in the contract)

• Per the contractual terms, Dompé will request review of any defined deliverables from the study (abstracts, publications, etc.)

• At any point, you will be able to go into your account in the system and see the status of your proposal(s) and/or study(s)

• The first step is to click on the Submit a Proposal button

• This will take you to the first of two parts of the proposal submission process

• Part one is an online form that captures categorical information as well as study design information; this information is collected directly in the system to enable the proper internal routing and classification of the proposal. You will also submit your contact information, study rationale, current healthcare license number (if applicable), and curriculum vitae in this step.

• Part two of the process captures the detail of the study you are proposing, including aspects of the overall study design, target population, statistical analysis plan, etc.

  • There are two options in completing part two of the process:

    • 1) You can download and complete the provided templates or

    • 2) You can submit your own full protocol and budget

  • Regardless of which option you choose, you will attach the completed templates or protocol and budget into the system and the file will be reviewed by Dompé personnel

• After you have submitted each step, you will receive an automatic notification from the system via email confirming success of your submission

• At any time, you can then login and check the status of the proposal, add additional attachments to the system, or review correspondence that you have received from Dompé

• Conduct a high-quality ethical study

• Register the protocol on a public web site (e.g. ClinialTrials.gov, ICTRP)

• Complete required documentation in a timely manner

• Meet applicable deadlines as defined in the legal agreement

• Ensure patient safety

• Report any safety issues and adverse events in a timely fashion as defined in the legal agreement

• Disclose any affiliation or financial conflicts of interest

• Ensure financial transparency

• Ensure patient confidentiality

• Publish study results in an appropriate, transparent and timely manner

• Ask questions whenever needed

• Professional interactions with Dompé employees who ensure patient safety is of paramount importance

• Timely responses to any inquiries or requests coming from the sponsor, including decisions on completed proposals

• No involvement of Dompé sales or marketing employees in any aspect of an IIR

• Compliance with data protection laws with respect to the personally identifiable information of the sponsors/investigators

• An easy to use information portal

• Once reviewed for completeness, all proposals go through a scientific review process that is made up of key personnel for the given product/therapy area

• Decisions are made based primarily on the overall scientific rationale of the proposal; additional considerations include alignment with Dompé' areas of scientific interest, qualifications of the investigator-sponsor, availability of internal funding resources, a market assessment of any funding requested, and evaluation if similar research is already being conducted or has been conducted.

• Please contact the Dompé IIR team at iir@Dompé.com